Demonstration Project For Competitive Bidding of
Clinical Laboratory Services
Summary of Legislation
Section 302(b) of the Act amends section 1847(e) (42 U.S.C. 1395w-3) --“Competitive
Acquisition of Certain Items and Services,” to include a demonstration
project for clinical laboratory services. The demonstration must apply competitive
acquisition for payment for clinical laboratory services, which would otherwise
be made under Medicare Part B fee schedule. Under this statute, pap smears and
colorectal screening tests are excluded from this demonstration. Requirements
under the Clinical Laboratory Improvement Amendments (CLIA) as mandated in section
353 of the Public Health Service Act are applicable. The statute does not specify
an implementation date. An initial report to Congress is due not later than
December 31, 2005. Progress reports and final reports are required. The total
amounts to be paid to contractors in a competitive acquisition area are expected
to be less than the total amounts that would otherwise be paid. The payment
basis determined for each competitive acquisition area will be substituted for
the payment basis. Contracts are to be re-competed every 3 years, and multiple
winners are expected in each competitive acquisition area. The statute does
not specify the number or location of demonstration sites.
Current Status
CMS awarded a task order contract to RTI International (and their subcontractor
Palmetto GBA, LLC) on September 30, 2004. John Kautter, Ph.D. is the Project
Director.
The purposes of this task order are to assist CMS in the design (Phase I:
demonstration design, develop solicitation and bid process, claims processing
plan, management), and operation (Phase II: operate bid sites of the demonstration.
CMS will hold an Open Door Forum later this fall to gather input and information
from the public regarding the initial phase of the contract. There is also an
ongoing dedicated email box (lab_bid_demo@cms.hhs.gov)
that provides a way to the public for ongoing and direct communication with
CMS regarding this demonstration project.
Submission of written materials pertaining to this demonstration
Anyone wishing to share information should send written materials to Linda
Lebovic, the project officer for the demonstration, via email at: LAB_BID_DEMO@cms.hhs.gov or through
the US mail at:
Linda Lebovic
Mailstop C4-17-27
Demonstrations Group
CMS - ORDI
7500 Security Blvd
Baltimore, MD 21244-1850
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Last Modified on Wednesday, October 06, 2004
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